NCT07586618 First-in-human Study of a New Treatment (4A10) for Patients With Relapsed or Hard-to-treat Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma, Focused on Safety and How the Drug Behaves in the Body and Early Signs of Effect.
| NCT ID | NCT07586618 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Allterum Therapeutics, Inc |
| Condition | Lymphoblastic Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2026-06-01 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
ALT-101 is a first-in-human Phase 1 clinical trial testing a new antibody drug called 4A10 in patients with relapsed or hard-to-treat acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma. 4A10 is a targeted therapy designed to recognize and attach to a specific protein (CD127) found on leukemia cells. Once it binds, it works in two ways: it blocks growth signals that help cancer cells survive, and it helps the immune system find and destroy those cancer cells. In this study, patients receive 4A10 through an intravenous (IV) infusion once a week. The main goal of the trial is to find out if the drug is safe, what dose can be given, and how the body processes it. Researchers will also look for early signs that the treatment may be working. The study starts with small groups of patients receiving increasing doses to carefully monitor safety. Each patient is closely observed during the first treatment cycle (about 4-6 weeks) to watch for side effects. If the treatment is helping and is well tolerated, patients may continue treatment for up to six cycles. Overall, this study is an early step in testing a new, targeted immune-based therapy for difficult-to-treat blood cancers.
Eligibility Criteria
Key Inclusion Criteria: 1. Confirmed diagnosis of T/B-ALL or T/B-LL 2. Relapsed or refractory disease without curative options 3. Adequate organ function and performance status Key Exclusion Criteria: 1. Patients with CNS3 disease 2. Patients with DNA fragility syndromes (e.g., Fanconi, Bloom), trisomy 21 (Down Syndrome) 3. Prior exposure to anti-CD127 therapies 4. Uncontrolled infections
Contact & Investigator
Eric Schafer, MD
STUDY CHAIR
Baylor College of Medicine
Frequently Asked Questions
Who can join the NCT07586618 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lymphoblastic Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07586618 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07586618 currently recruiting?
Yes, NCT07586618 is actively recruiting participants. Contact the research team at skudchadkar@allterum.com for enrollment information.
Where is the NCT07586618 trial being conducted?
This trial is being conducted at Aurora, United States, Philadelphia, United States, Fort Worth, United States, Houston, United States.
Who is sponsoring the NCT07586618 clinical trial?
NCT07586618 is sponsored by Allterum Therapeutics, Inc. The principal investigator is Eric Schafer, MD at Baylor College of Medicine. The trial plans to enroll 24 participants.